FDA’s Gottlieb outlines new goals in budget plan, looking to spur drug reviews

President Donald Trump’s budget sought a boost in funding for the FDA and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plans to pursue.

Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital health.

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release

January 29, 2018

Contact

Consumers

Recall Department
recall@kareway.com
310-532-0009

 

Announcement

Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

An Analysis Of FDA FY2017 Drug GMP Warning Letters

By Barbara Unger, Unger Consulting Inc.

FDA Provides Some Guidance for 503B Facilities

 

On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.

Compounding pharmacy increasingly popular during flu season

 

Compounding pharmacy has become increasingly popular across Central Florida since the uptick in flu cases.

Eyewitness News reported last week that there is a shortage of the generic version of Tamiflu and the price of brand-name of Tamiflu has skyrocketed.

FDA Releases Compounding Priorities Plan

The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.

Top Organizations Urge a Concerted Effort To Improve Safety in Hospital Compounding

Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was released today reflecting the recommendations of major stakeholders for additional steps needed to improve patient safety relative to compounded medicines.  The paper was the outcropping of a milestone dialogue where top pharmacy, healthcare provider, hospital and patient organizations assessed progress made since the 2012 NECC tragedy and the subsequent enactment of the Drug Quality and Security Act by Congress.

Hospitals face shortage of IV bags amid flu outbreak

 

TREASURE VALLEY — Hospitals across the nation continue to battle a shortage of IV solution bags – now, amid an early and aggressive flu season.

CLEAN BENCHES

 

Providing Additional Clean Room Technology

The laminar flow clean bench is a work bench or similar enclosure which has its own filtered air supply. The clean bench was developed as an adjunct to clean room technology (the need to protect the work from contamination). In recent years, the use of the clean bench, laminar flow cabinet or laminar flow hood has spread from research and manufacturing to other fields such as aerospace, bioscience, pharmaceutical production and food processing.

FDA Unveils Guidance To Smooth Generic-Drug Path

Law360, New York (January 3, 2018, 5:48 PM EST) — The U.S. Food and Drug Administration on Wednesday unveiled draft guidance for the pharmaceutical industry and an internal manual of policies and procedures that it says will streamline the approval process for generic drugs, in part by reducing the number of times an application must be reviewed.